A multicenter,randomized,controlled clinical trial of early vitrectomy for diffuse diabetic macular edema.

A multicenter,randomized,controlled clinical trial of early vitrectomy for diffuse diabetic macular edema. - A multicenter,randomized,controlled clinical trial of early vitrectomy for diffuse diabetic macular edema.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008957

Enrollment

162

Registered

2012-10-01

Start date

2012-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diffuse diabetic macular edema

Interventions

Pars plana vitrectomy and follow up for 24 months. Intravitreal injection of triamcinolone acetonide and follow up for 24 months.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Aged 18 years or older. Diffuse DME(CMT 300microns < determined by OCT). BCVA between 58 and 74 letters of a ETDRS visual acuity scale.

Exclusion criteria

Exclusion criteria: Eyes of signs of vitreomacular traction on biomicroscopy or OCT. Eyes with active proliferative DR. Eyes with known a history of glaucoma,optic nerve atrophy,vitrectomy,intravitreal injection,subtenon injection. Eyes with known a history of photocoagulation within 3 months,cataract operation within 6 months. Patients with any of serious heart disease, cerebrovascular disease,blood disorder, renal failure, malignant tumor, systemic steroids. Patients with HbA1c 10% or higher, or systolic blood pressure of more than 180 mmHg or diastolic blood pressure more than 110 mmHg. Patients with known as steroid responder.

Design outcomes

Primary

Measure	Time frame
visual acuity central macular thickness	—

Countries

Japan

Contacts

Public ContactTaiji Sakamoto

Kagoshima University Graduate School of Medical and Dental Science Department of Ophthalmology

tsakamot@m3.kufm.kagoshima-u.ac.jp099-275-5402

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026